510(k) · Cleared
ClearedLiquidchek Cardiac Markers Plus Control LT; Level 1C, Level 2, Level 3, Trilevel Minipak
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Dec 27, 2012 as substantially equivalent to K050537 (Bio-Rad, 2005) after a 29-day review. Its family tree reaches back 6 generations to 1996. 1 later device descends from it.
- Decided
- Dec 27, 2012
- Review
- 29 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K961828 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK961828 Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688)Bio-Rad · 1996
- 5 generations backK980556 Liquichek Cardiac Markers Control LTBio-Rad · 1998
- 4 generations backK012656 Liquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648Bio-Rad · 2001
- 3 generations backK021498 Liquichek Cardiac Markers Control LT Level 1, 2, 3, and TrilevelBio-Rad · 2002
- 2 generations backK040277 Liquichek Cardiac Marker Control LTBio-Rad Laboratories, Inc. · 2004
- 1 generation backK050537 Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers…Bio-Rad · 2005
- This deviceK123663 Liquidchek Cardiac Markers Plus Control LT; Level 1C, Level 2, Level…Bio-Rad Laboratories · 2012
- Descendant · cites it directly · 0 of its ownK152117 Dropper hsCRP High Sensitivity CRP ControlQuantimetrix Corporation · 2016
Most influential descendants
Showing 1 of 1 · See all- K152117Dropper hsCRP High Sensitivity CRP ControlQuantimetrix Corporation · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K961828 | Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688) | Bio-Rad | 1996 | — |
| −5 | K980556 | Liquichek Cardiac Markers Control LT | Bio-Rad | 1998 | — |
| −4 | K012656 | Liquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648 | Bio-Rad | 2001 | — |
| −3 | K021498 | Liquichek Cardiac Markers Control LT Level 1, 2, 3, and Trilevel | Bio-Rad | 2002 | — |
| −2 | K040277 | Liquichek Cardiac Marker Control LT | Bio-Rad Laboratories, Inc. | 2004 | — |
| −1 | K050537 | Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers Plus Control… | Bio-Rad | 2005 | — |
| 0 (this device) | K123663 | Liquidchek Cardiac Markers Plus Control LT; Level 1C, Level 2, Level 3… | Bio-Rad Laboratories | 2012 | — |
| +1 | K152117 | Dropper hsCRP High Sensitivity CRP Control | Quantimetrix Corporation | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JJY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K050537 | Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers Plus Control LT…Summary page 2…ers Plus Control LT claims substantial equivalence to the LIquichek Cardiac Markers Plus Control LT currently in commercial distribution (K050537). Table 1 (below) contains comparison information of similarities and differences between the new and predicate d… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152117 | Dropper hsCRP High Sensitivity CRP Control | 2016 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K152117 (Quantimetrix Corporation, 2016) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K050537.
How does its category compare?
All JJY devicesJJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · JJY
3in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJY
78in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJY
13in 2025
MAUDE reports naming product code JJY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 11 | 49 | 5 | 2 |
| 2008 | 7 | 54 | 0 | 1 |
| 2009 | 8 | 80 | 2 | 3 |
| 2010 | 10 | 109 | 6 | 3 |
| 2011 | 14 | 120 | 1 | 6 |
| 2012 | 13 | 40 | 3 | 20 |
| 2013 | 16 | 82 | 2 | 5 |
| 2014 | 10 | 49 | 2 | 4 |
| 2015 | 4 | 153 | 1 | 4 |
| 2016 | 1 | — | 3 | 13 |
| 2017 | 3 | 78 | 4 | 12 |
| 2018 | 0 | — | 3 | 7 |
| 2019 | 0 | — | 4 | 1 |
| 2020 | 0 | — | 6 | 7 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 0 | — | 3 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 2 | 13 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Liquichek Cardiac Markers Plus Control LT is intended for use as a quality control
serum to monitor the precision of laboratory testing procedures for the analytes
listed in this package insert.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123663 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123663: Liquidchek Cardiac Markers Plus Control LT; Level 1C, Level 2, Level 3, Trilevel Minipak.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123663
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026